NIH-funded research U01 cooperative agreement

PBPK-based predictors for long-acting injectable suspensions

Official title: Development of PBPK Model-Based Mechanistic IVIVCs for Long-Acting Injectable Suspensions

Funded at University of Connecticut Storrs · NIH-11401621 · Data updated 2026-11-12

Researchers will build computer models to predict how long-acting injectable suspensions release medicine in the body, helping ensure effective and safe dosing for patients.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Connecticut Storrs
NIH-funded
Lab location1 site (Storrs-Mansfield, United States)
Project startSeptember 1, 2024
Project endAugust 31, 2027
Funding year2026
Award (this year)$362,790
NIH project number5U01FD008304-03
Project IDNIH-11401621 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are patients who could benefit from long-acting injectable therapies and participate in future development or testing of LAI products and related models.

Less likely to help

Patients not using LAI therapies or outside the scope of this modeling effort may not directly benefit from this project.

What this research studies

This project uses physiologically based pharmacokinetic models to connect how LAI suspension formulations release drug at the injection site with how the medicine behaves in the body over time. The team will study how formulation attributes influence depot formation and local physiology to improve in silico predictions of drug release and bioavailability. By linking formulation factors to in vivo outcomes, they aim to support robust IVIVCs and facilitate generic LAI development. The work combines mechanistic modeling with experimental data to better anticipate patient responses and dosing needs. Results could help patients access reliable LAI therapies sooner with clearer guidance for regulators and manufacturers.

Why it matters

Potential benefit: If successful, this work could make LAI medicines more predictable and affordable, improving access and treatment consistency for patients needing long-acting therapies.

How similar studies have gone: Previous modeling efforts have shown promise in predicting drug release and guiding formulation decisions, but robust IVIVCs for LAI suspensions remain an area of active development.

Where this research is happening

  • University of Connecticut Storrs
    Storrs-Mansfield, United States
    Active

Researchers

  • Principal investigator: Burgess, Diane Jane — University of Connecticut Storrs
  • Study coordinator: Burgess, Diane Jane

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.